Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

Overview

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Full Title of Study: “Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2006

Interventions

  • Drug: MALG
    • 30 minute application

Arms, Groups and Cohorts

  • Experimental: 1
    • MALG

Clinical Trial Outcome Measures

Primary Measures

  • Change in cholinesterase level
    • Time Frame: 1 day

Secondary Measures

  • Clinical evidence of cholinesterase inhibition
    • Time Frame: 1 day
  • Local tolerability
    • Time Frame: 1 day
  • Cure of head lice 14 days after last treatment
    • Time Frame: 2 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Confirmed active head lice infestation – Parent or guardian must be able to apply treatment Exclusion Criteria:

  • Allergy to pediculicides or hair care products – Scalp conditions other than head lice – Previous head lice treatment within the past 4 weeks – Current antibiotic treatment

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taro Pharmaceuticals USA
  • Provider of Information About this Clinical Study
    • Medical Director, Taro Pharmaceuticals USA

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